Tests PRAX-628 in adults with focal or generalized tonic-clonic seizures
Tests the drug PRAX-628 in adults with focal or tonic-clonic seizures.
Plain-language title generated from the registry record
Registry title: An Open Label Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adults With Focal Onset or Tonic-Clonic Seizures
Key facts
- Where
- Madrid, SpainSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06908356, who can take part
Where in Spain
- MadridMadrid, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Praxis Precision Medicines
- Trial code
- NCT06908356
- Record updated
- 3 April 2025
- Original description
An Open Label Clinical Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adult Patients With Focal Onset or Primary Generalized Tonic-Clonic SeizuresRead full original descriptionShow less
An Open Label Clinical Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adult Patients With Focal Onset or Primary Generalized Tonic-Clonic Seizures
An Open Label Clinical Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adult Patients With Focal Onset or Primary Generalized Tonic-Clonic Seizures
Inclusion: A diagnosis of focal onset seizures or idiopathic generalized tonic clonic seizures; Evidence by computed tomography (CT) or magnetic resonance imaging (MRI) in the past that has ruled out a progressive cause of epilepsy; Participant must have been receiving stable doses of allowable ASMs (a minimum of 1 and a maximum of 3 ASMs); Participant and/or caregiver (if applicable) self-reports at least 2 countable focal onset seizures per month for focal onset patients, or 1 countable generalized tonic-clonic seizure per month in the 3 months immediately prior to the Screening/Observation Period for PGTCS patients.
Exclusion: History of pseudo or psychogenic seizures, or cluster seizures only, within the 12-month period preceding study entry where the individual seizures cannot be counted, or an episode of convulsive status epilepticus requiring hospitalization and intubation in the 12 months prior to Screening; History of neurosurgery for seizures <1 year prior to enrollment, or radiosurgery <2 years prior to enrollment; Has received any other experimental or investigational drug, device or other therapy within 30 days or 5 half-lives (whichever is longer) prior to Screening, or any prior use of gene therapy; Felbamate: If used as a concomitant ASM, patients must be on felbamate for at least 2 years, with a stable dose for 2 months prior to Screening. If a patient received felbamate in the past, it must have been discontinued 2 months prior to Screening; Planned epilepsy surgery during the course of the clinical trial; Schizophrenia and obsessive-compulsive disorder, or other serious mental health disorders; Active suicidal plan/intent in the past 6 months, or a history of suicide attempt in the last 2 years, or more than 1 lifetime suicide attempt; Participants with a history of malignancy, myeloproliferative or lymphoproliferative disorders within the past 5 years are excluded; History of cardiac disease(s)/cardiac conduction disorders/or cardiac structural abnormality(ies); Is pregnant or breastfeeding at the time of Screening, or has a positive serum pregnancy test at Screening or is planning to become pregnant during the clinical trial or within 14 days of the last study drug dose; Vigabatrin: Use in the last 5 years without stable visual fields tested twice over the 12 months after the last dose of vigabatrin.